2023-26422. CDC Recommendations for Hepatitis C Testing Among Perinatally Exposed Infants and Children-United States, 2023

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

General notice.

SUMMARY:

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the availability of the final CDC Recommendations for Hepatitis C Testing Among Perinatally Exposed Infants and Children—United States, 2023.

DATES:

The final document was published as an MMWR Reports & Recommendations on November 3, 2023.

ADDRESSES:

The document may be found in the docket at www.regulations.gov, Docket No. CDC–2022–0116 and at https://www.cdc.gov/​mmwr/​volumes/​72/​rr/​rr7204a1.htm?​s_​cid=​rr7204a1_​w.

FOR FURTHER INFORMATION CONTACT:

Lakshmi Panagiotakopoulos, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop U12–3, Atlanta, GA 30329. Telephone: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

In 2021, CDC determined that Recommendations for Hepatitis C Testing Among Perinatally Exposed Infants and Children—United States, 2023 constituted influential scientific information (ISI) that will have a clear and substantial impact on important public policies and private sector decisions. As such, the recommendations underwent peer review as required by Part II Section D of the HHS Information Quality Guidelines ( https://aspe.hhs.gov/​hhs-guidelines-ensuring-maximizing-disseminated-information). HHS developed these guidelines in accordance with the OMB issued Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of lnformation Disseminated by Federal Agencies, 67 FR 8452 (Feb. 22, 2002) and the Information Quality Act Public Law 106–554, 515(a) (2000). CDC elected to use specialists in the field who were not involved in the development of the recommendations. CDC solicited nominations for reviewers from the American Academy of Family Physicians, American Academy of Pediatrics, American Association for the Study of Liver Diseases, American College of Obstetricians and Gynecologists, and the North American Society for Pediatric Gastroenterology, Hepatology & Nutrition. Six clinicians with expertise in hepatology, gastroenterology, internal medicine, infectious diseases, and/or pediatrics provided structured peer reviews. Specifically, CDC asked reviewers to focus their reviews on the following criteria:

• Methodology (studies included in the evidence review, methods used to assess the evidence, clarity of evidence findings, identification of limitations or uncertainties)
• Recommendations (reviewer agreement with CDC's conclusions, suggestions for clarifying recommendations)
• Potential impact and implementation (whether implementing recommendations would improve health outcomes, any resources or tools that would facilitate implementation)
• Other comments for CDC consideration

A list of peer reviewers and CDC's responses to peer review comments are available at CDC's Viral Hepatitis Influential Scientific Information web page at https://www.cdc.gov/​hepatitis/​policy/​isireview/​index.htm.

In addition, on November 22, 2022, CDC published a notice in the Federal Register (87 FR 71330) to obtain public comment on the draft recommendations for hepatitis B screening and testing. The comment period closed on January 27, 2023. CDC received 22 comments pertaining to the draft recommendations document. Public comments were received from the general public, health care providers, advocacy groups, industry, medical professional associations, thinktanks and a public health department.

Twelve of the comments expressed full support for the recommendations. Two comments were critical of the approach and recommended keeping the current recommendation of HCV antibody testing at age ≥18 months. CDC also received comments about: testing infants and children when maternal HCV status is unknown; follow up after receiving test results; testing siblings of perinatally infected infants; stigma and harms of HCV testing; suggested scientific content and implementation guidance; and editorial comments. CDC addressed these comments by correcting, clarifying, or updating content in the final recommendations. A summary of public comments and CDC's response can be found in the Documents tab of the docket, as well as CDC Stacks at https://stacks.cdc.gov/​view/​cdc/​134020.

Tiffany Brown,

Executive Secretary, Centers for Disease Control and Prevention.